Methodological Quality of Clinical Practice Guidelines for Pharmacological Prophylaxis of Venous Thromboembolism in Hospitalized Adult Medical and Surgical Patients and Summary of the Main Categories of Recommendations Included in High-Quality CPGs: A Sys

Venous thromboembolism (VTE) is a complex multifactorial disease with an average annual incidence of approximately 1 per 1000 in the adult population. Recommendations about pharmacological prophylaxis of VTE in adult hospitalized surgical and medical patients are available in clinical practice guidelines (CPGs) to optimize healthcare delivery and improve patient outcomes. The aim of this study was to examine the methodological quality of CPGs for pharmacological prophylaxis of VTE in adult hospitalized medical and surgical patients and to summarize the main categories to contextualize the recommendations included in high-quality CPGs. Methodology: The study used the ADAPTE to contextualize in categories the main recommendations of the high-quality CPGs assessed by the Appraisal of Guidelines for Research and Evaluation (AGREE II). Results: Fourteen CPGs were screened for assessment of quality methodology by AGREE II instrument. Seven of fourteen CPGs were selected as high-quality (>60%) across domains 3 and 6 to contextualize the recommendations in categories. Conclusion: Seven CPGs evaluated by AGREE had scores above 60% in domains 3 and 6. The scope addressed by the high-quality CPGs included important aspects of pharmacological prophylaxis of VTE in hospitalized patients

Guidelines’ recommendations for the treatment-resistant depression: A systematic review of their quality

Copyright: © 2023 Gabriel et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.Introduction: Depression is a serious and widespread mental health disorder. A significant proportion of patients with depression fail to remit after two antidepressant treatment trials, a condition named treatment-resistant depression (TRD). Clinical practice guidelines (CPGs) are instruments aimed to improve diagnosis and treatment. This study objective is to systematically appraise the quality and elaborate a comparison of high-quality CPGs with high-quality recommendations aimed at TRD. Methods and analysis: We searched several specialized databases and organizations that develop CPGs. Independent researchers assessed the quality of the CPGs and their recommendations using AGREE II and AGREE-REX instruments, respectively. We selected only high-quality CPGs that included definition and recommendations for TRD. We investigated their divergencies and convergencies as well as weak and strong points. Results: Among seven high-quality CPGs with high-quality recommendations only two (Germany's Nationale Versorgungs Leitlinie-NVL and US Department of Veterans Affairs and Department of Defense-VA/DoD) included specific TRD definition and were selected. We found no convergent therapeutic strategy among these two CPGs. Electroconvulsive therapy is recommended by the NVL but not by the VA/DoD, while repetitive transcranial magnetic stimulation is recommended by the VA/DoD but not by the NVL. While the NVL recommends the use of lithium, and a non-routine use of thyroid or other hormones, psychostimulants, and dopaminergic agents the VA/DoD does not even include these drugs among augmentation strategies. Instead, the VA/DoD recommends ketamine or esketamine as augmentation strategies, while the NVL does not mention these drugs. Other differences between these CPGs include antidepressant combination, psychotherapy as a therapeutic augmentation, and evaluation of the need for hospitalization all of which are only recommended by the NVL. Conclusions: High-quality CPGs for the treatment of depression diverge regarding the definition and use of the term TRD. There is also no convergent approach to TRD from currently high-quality CPGs.F.C.G. is a fellow of the Conselho Nacional de Pesquisa e Tecnologia (CNPq, grant number 141811/2020-0).info:eu-repo/semantics/publishedVersio

Summary of recommendations: a resource to support the process of adaptation of the clinical practice guidelines for the pharmacological treatment of depression

A depressão é um dos maiores problemas de saúde pública do século XXI. Guias de prática clínica (GPCs) estão disponíveis para o tratamento da depressão e têm como objetivo fornecer a melhor e mais recente evidência disponível para os cuidados dos pacientes. Visando reduzir a duplicação de esforços e realizar a adequação de GPC ao contexto local o objetivo desta pesquisa é sintetizar as recomendações de GPCs de alta qualidade sobre o tratamento farmacológico da depressão em adultos na atenção primária. Foram realizadas as etapas busca sistemática dos GPCs, avaliação e seleção dos GPCs de melhor qualidade, e elaboração da síntese de recomendações de acordo com o preconizado no método ADAPTE. Foram considerados os GPCs com recomendações para o tratamento farmacológico da depressão em adultos em atenção primária, em língua inglesa, portuguesa ou espanhola, publicados a partir de 2011. Para a avaliação da qualidade dos GPCs, foi utilizado o Appraisal of Guidelines for Research & Evaluation II (AGREE II) sendo considerados de alta qualidade os GPCs com 80% ou mais no domínio \"rigor metodológico\". As características associadas à alta qualidade dos GPCs foram analisadas por meio do teste estatístico de Fisher. A extração das recomendações foi realizada de modo independente por dois avaliadores e estas foram organizadas em tópicos. Dos 28 GPC avaliados apenas cinco (18%) foram considerados de alta qualidade. A realização de revisão sistemática e da revisão externa e a aplicação de consenso formal foram características associadas à alta qualidade. Na síntese, além dos GPCs de alta qualidade, foram incluídos 2 GPCs muito empregados na prática clínica. Constatou-se que a maioria dos GPCs traz recomendações concordantes e complementares. Quase todos os GPCs recomendam o uso de inibidores seletivos de recaptação de serotonina como primeira escolha de tratamento. Uma das principais divergências é a recomendação de agomelatina, milnaciprano e mianserina por um dos GPCs como opção de primeira linha de tratamento. A pesquisa demonstra que a qualidade dos GPCs está aquém do desejável, tal qual evidenciado em outros estudos. A elaboração da síntese de recomendações permitiu evidenciar que há um GPC que se destacou por recomendar o uso de medicamentos considerados pouco eficazes na depressão. Considerando que a maioria das recomendações eram concordantes e os GPCs complementavam-se, essa síntese pode contribuir para que sejam realizadas discussões e adaptações locais, favorecendo a elaboração de novos GPCs que possam atender às necessidades de distintos grupos de usuários e demandas regionais.Depression is one of the most significant public health problems of the 21st century. Clinical practice guidelines (CPGs) are available for treating depression and are used for providing the best and latest evidence available for patient care. To avoid the duplication of effort and allow the adequacy of CPGs to regional healthcare networks, the objective of this study is to summarise the recommendations of high-quality CPGs on the pharmacological treatment of depression in adults in the primary healthcare network. The stages of this study were the systematic search of CPGs, analysis and selection of high-quality CPGs, and summarisation of the recommendations according to the ADAPTE guidelines. The CPGs published in English, Portuguese, and Spanish since 2011 with recommendations for the pharmacological treatment of depression in adults in the primary healthcare network were considered. The Appraisal of Guidelines for Research & Evaluation II (AGREE II) was used to evaluate the quality of CPGs. CPGs with a score of >=80% in the domain \'methodological rigour\' were considered high-quality. The factors associated with high quality were analysed using Fisher\'s exact test. The recommendations were extracted independently by two evaluators and organised into topics. Of the 28 evaluated CPGs, five (18%) were considered high-quality. The inclusion of systematic reviews and external reviews and the application of formal consensus were associated with high quality. In addition to high-quality CPGs, two CPGs commonly used in clinical practice were included in the summary. The recommendations provided by most CPGs were consistent and complementary. Almost all CPGs recommended using selective serotonin reuptake inhibitors as the first choice of treatment. One of the main divergences was the recommendation of agomelatine, milnacipran, and mianserin by one CPG as a first-line treatment option. The quality of CPGs was below desirable, and this result was corroborated by other studies. The analysis of the recommendations indicated that one CPG advised using medications with low efficacy in treating depression. Provided that most suggestions were concordant and the CPGs were complementary, this summary may contribute to local discussions and adaptations and promote the development of new CPGs that meet the needs of different user groups and regional demands

Clinical guidelines for the treatment of depression: analysis of factors associated with quality and comparison of recommendations for nonresponding patients and for patients with resistant depression

Diretrizes clínicas (DCs) de alta qualidade são importantes para a assistência efetiva de pacientes com doenças crônicas, incluindo a depressão. A depressão é um dos principais problemas de saúde mundial, sendo um dos transtornos psiquiátricos mais comumente encontrados na prática médica, afetando cerca de 300 milhões de pessoas. Além de sua natureza debilitante e onerosa, muitas vezes pode levar a desfechos graves, tal como o suicídio, principalmente em pacientes que não respondem aos tratamentos. Assim, o objetivo geral desta tese foi identificar fatores das DCs associados à qualidade metodológica desses documentos e de suas recomendações, e comparar as recomendações para duas situações de falhas da farmacoterapia: pacientes não respondedores e pacientes com depressão resistente ao tratamento (DRT). Operacionalmente, foram feitas revisões sistemáticas da literatura em bases científicas e específicas de DCs, e incluídas DCs publicadas nos últimos onze anos que contivessem recomendações para o tratamento farmacológico de adultos com depressão. Para avaliação geral das DCs, foi aplicado o instrumento AGREE II, e para avaliação específica das recomendações, o instrumento AGREE-REX. As DCs foram consideradas de alta qualidade quando pontuaram com escores maiores ou iguais a 60% (no estudo descrito no capítulo 2) e maiores ou iguais a 80% (no estudo descrito no capítulo 3) no domínio 3 (Rigor de desenvolvimento) do AGREE II. As DCs com recomendações de alta qualidade foram as que pontuaram com mais de 60% no domínio 1 (Aplicabilidade Clínica) do AGREE-REX. Das 63 DCs selecionadas, 17 (27%) apresentaram alta qualidade, e 7 (11%) apresentaram recomendações de alta qualidade. Os fatores associados à maior qualidade foram gerenciamento de conflitos de interesses, equipe multiprofissional e tipo de instituição. A inclusão de representante do paciente na equipe também foi associada a recomendações de maior qualidade. Verificou-se que a maioria das DCs concorda com a necessidade de: reavaliar o diagnóstico, a presença de comorbidades, a adesão ao tratamento, ajustar a dosagem do antidepressivo e adicionar psicoterapia como os primeiros passos para aqueles que não respondem ao tratamento antidepressivo de primeira linha. Em relação às recomendações, há falhas importantes, incluindo a não apresentação de definição padronizada de resposta adequada/inadequada/parcial, e o não estabelecimento de tempo de tratamento necessário para declarar DRT. Todas as DCs incluíram a possibilidade de substituição do antidepressivo, potencialização com outros medicamentos e combinação de antidepressivos. Todavia, três DCs não recomendaram uma sequência entre eles. Por fim, verificou-se que das 17 DCs de alta qualidade e das 7 DCs com recomendações de alta qualidade, apenas duas incluíram definição e recomendações para DRT. Não existe consenso entre as DCs de alta qualidade quanto à definição e uso do termo DRT. Não foi possível extrair uma estratégia terapêutica convergente para DRT em adultos. Os resultados obtidos reforçam a necessidade de maior foco no aprimoramento da qualidade das DCs e de suas recomendações, especialmente nos subgrupos relativos à resposta inadequada ao tratamento e a DRT, nas quais as definições não são claras.High-quality clinical practice guidelines (CPGs) are important for treating patients with chronic diseases such as depression. Depression is a major health concern worldwide, affecting approximately 300 million people. It is one of the most prevalent psychiatric disorders in medical practice. It is not only debilitating and costly but can also lead to tragic consequences such as suicide, particularly in patients who do not respond to treatment. The objective of this thesis was to identify CPGs factors associated with the methodological quality of these documents and their recommendations. Furthermore, this thesis aimed to compare the recommendations in two pharmacotherapy failure situations: inadequate response to treatment and treatment-resistant depression (TRD). Systematic literature reviews were conducted on scientific and CPG-specific databases. Reviews were also conducted on CPGs published in the last eleven years that included recommendations for pharmacological treatment of adults with depression. The AGREE II instrument was used for the CPGs general assessment, while the AGREE-REX instrument was used specifically to assess their recommendations. CPGs were considered high quality if they achieved a score of at least 60% in the study mentioned in Chapter 2 and a score of at least 80% in the study mentioned in Chapter 3 in the AGREE II, rigour of development domain. The CPGs with high-quality recommendations were those that scored greater than 60% in Domain 1 (Clinical Applicability) of the AGREE-REX. Of the 63 selected CPGs, 17 (27%) were high quality, and 7 (11.1%) had recommendations of high quality. Factors associated with higher quality were conflict of interest management, multi-professional team, and type of institution. Inclusion of a patients representative on the team was associated with higher quality recommendations. Most CPGs agreed with the need to reassess diagnoses, comorbidities, and treatment adherence. They also agreed on adjusting antidepressant dosage and providing psychotherapy as a first step for patients who do not respond to first-line antidepressant treatment. There are significant shortcomings in the recommendations. In particular, the lack of a standardized definition of adequate, inadequate, or partial response to treatment and the lack of clarity surrounding the duration of treatment required to establish TRD. All CPGs included the possibility of antidepressant substitution, potentiation with other drugs, and a combination of antidepressants. However, three CPGs did not recommend a preferred sequence for these interventions. Finally, of the 17 high-quality CPGs and the 7 CPGs with high-quality recommendations, only two included definition and recommendations for TRD. There is no consensus among the high-quality CPGs regarding the definition and use of the term TRD. Ultimately, finding a convergent therapeutic strategy for TRD in adults was not possible. These results highlighted the need to focus more on improving the quality of CPGs and their recommendations, especially in the subgroups related to inadequate response to treatment and TRD, where definitions are unclear

Pharmacological treatment of depression: A systematic review comparing clinical practice guideline recommendations.

Depression affects over 300 million individuals worldwide and is responsible for most of the 800,000 annual suicides. Clinical practice guidelines (CPGs) for treatment of depression, founded on scientific evidence, are essential to improve patient care. However, economic and sociocultural factors may influence CPG elaboration, potentially leading to divergences in their recommendations. Consequently, we analyzed pharmacological recommendations for the treatment of depression from the most relevant CPGs. We included four CPGs with scores ≥ 80% for Domain 3 (rigor of development) on the Appraisal of Guidelines for Research and Evaluation and two other commonly used CPGs. The recommendations, their strengths, and the level of evidence were extracted from each CPG by two independent researchers and grouped as follows: (1) general recommendations for the pharmacological treatment for depression (suicide risk, acute treatment, continuation and maintenance phases, and treatment discontinuation); (2) treatment of non-responsive or partially responsive patients; and (3) treatment for subtypes of depression (chronic, psychotic, catatonic, melancholic, seasonal, somatic, mixed, and atypical). Only 50% of CPGs included recommendations for the risk of suicide associated with pharmacotherapy. All CPGs included serotonin selective reuptake inhibitors (SSRIs) as first-line treatment; however, one CPG also included agomelatine, milnacipran, and mianserin as first-line alternatives. Recommendations for depression subtypes (catatonic, atypical, melancholic) were included in three CPGs. The strength of recommendation and level of evidence clearly differed among CPGs, especially regarding treatment augmentation strategies. We conclude that, although CPGs converged in some recommendations (e.g., SSRIs as first-line treatment), they diverged in cardinal topics including the absence of recommendations regarding the risk of suicide associated with pharmacotherapy. Consequently, the recommendations listed in a specific CPG should be followed with caution

Methodological guidelines and publications of benefit–risk assessment for health technology assessment: a scoping review protocol

Background Benefit–risk assessment (BRA) is used in multiple phases along the health technology’s life-cycle to evaluate the balance between the benefits and risks, as it is fundamental to all stakeholders. BRA and its methodological approaches have been applied primarily in the context of regulatory agencies. However, BRA’s application and extent in the context of health technology assessment (HTA) bodies remain less clear. Our goal is to perform a scoping review to identify and map methodological guidelines and publications on methods of BRA. This will be done considering the different phases of the life-cycle of health technologies to underline both the depth and extent of research concerning BRA, especially in the context of HTA.Methods and analysis This scoping review protocol was developed following the framework proposed by Arksey and O’Malley, and the updated guidelines by the Joanna Briggs Institute. We will include methodological publications that provide recommendations or guidelines on methods for BRA. We will conduct electronic searches on Medline (PubMed) and EMBASE (Ovid) databases; manual searches on the main websites of HTA bodies and drug regulatory organisations; and contact experts in the field. Systematic extraction forms will be used to screen and assess the identified publications by independent assessors. We will provide a qualitative synthesis using descriptive statistics and visual tools. Results will be summarised in systematic evidence tables and comparative evidence scoping charts.Ethics and dissemination This review will use data publicly available and does not require ethics approval. The results of this scoping review will contribute to scientific knowledge and act as a basis for methodologists, guideline developers and researchers for the development of BRA to inform regulatory decisions, reimbursement and coverage decision making. The results will be disseminated through peer-reviewed articles, conferences, policy briefs and workshops.Trial registration number Open Science Framework (https://doi.org/10.17605/OSF.IO/69T3V)

Factors associated with higher quality of clinical practice guidelines and their recommendations for the pharmacological treatment of depression: a systematic review

Objective The objective of this study was to assess the quality of clinical practice guidelines (CPGs) for the pharmacological treatment of depression along with their recommendations and factors associated with higher quality.Design We conducted a systematic review that included CPGs for the pharmacological treatment of depression in adults.Data sources We searched for publications from 1 January 2011 to 31 December 2021, in MEDLINE, Cochrane Library, Embase, PsycINFO, BVS and 12 other databases and guideline repositories.Eligibility criteria for selecting studies We included CPGs containing recommendations for the pharmacological treatment of depression in adults at outpatient care setting, regardless of whether it met the U.S. National Academy of Medicine criteria, or not. If a CPG included recommendations for both children and adults, they were considered. No language restriction was applied.Data extraction and synthesis Data extraction was also conducted independently and in duplicate, a process that was validated in a previous project. The quality of the CPGs and their recommendations were assessed by three independent reviewers using Appraisal of Guidelines for Research and Evaluation (AGREE II) and Appraisal of Guidelines for Research and Evaluation-Recommendations Excellence (AGREE-REX). A CPG was considered to be of high quality if AGREE II Domain 3 was ≥60%; while their recommendations were considered high if AGREE-REX Domain 1 was ≥60%.Results Seventeen out of 63 (27%) CPGs were classified as high quality, while 7 (11.1%) had high-quality recommendations. The factors associated with higher-scoring CPGs and recommendations in the multiple linear regression analyses were ‘Handling of conflicts of interest’, ‘Multiprofessional team’ and ‘Type of institution’. ‘Inclusion of patient representative in the team’ was also associated with higher-quality recommendations.Conclusions The involvement of professionals from diverse backgrounds, the handling of conflicts of interest, and the inclusion of patients’ perspectives should be prioritised by developers aiming for high-quality CPGs for the treatment of depression